Ibuprofen is in a group of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). Ibuprofen works by reducing hormones that cause inflammation and pain in the body.
Pseudoephedrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).
The combination of ibuprofen and pseudoephedrine is used to treat stuffy nose, sinus congestion, cough, and pain or fever caused by the common cold or flu.
Ibuprofen and pseudoephedrine may also be used for other purposes not listed in this medication guide.
Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. Do not use ibuprofen and pseudoephedrine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days.
Ibuprofen can increase your risk of life-threatening heart or circulation problems, including heart attack or stroke. Do not use this medicine just before or after having heart bypass surgery (also called coronary artery bypass graft, or CABG).
Seek emergency medical help if you have symptoms of heart or circulation problems, such as chest pain, weakness, shortness of breath, slurred speech, or problems with vision or balance.
Ibuprofen can also increase your risk of serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and can occur without warning at any time while you are taking ibuprofen.
Call your doctor at once if you have symptoms of bleeding in your stomach or intestines. This includes black, bloody, or tarry stools, or coughing up blood or vomit that looks like coffee grounds.Do not take more of this medication than is recommended. An overdose of ibuprofen can cause damage to your stomach or intestines.
Do not use ibuprofen and pseudoephedrine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take ibuprofen and pseudoephedrine before the MAO inhibitor has cleared from your body.
Taking an NSAID can increase your risk of life-threatening heart or circulation problems, including heart attack or stroke. This risk will increase the longer you use an NSAID. Do not use this medicine just before or after having heart bypass surgery (also called coronary artery bypass graft, or CABG).
NSAIDs can also increase your risk of serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and gastrointestinal effects can occur without warning at any time while you are taking an NSAID. Older adults may have an even greater risk of these serious gastrointestinal side effects.You should not use this medication if you are allergic to ibuprofen or pseudoephedrine, or if you have:
Ask a doctor or pharmacist about taking ibuprofen and pseudoephedrine if you have:
FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby during early pregnancy. However, taking ibuprofen and pseudoephedrine during the last 3 months of pregnancy may result in birth defects and prolonged labor and delivery. Do not take ibuprofen and pseudoephedrine during the last 3 months of pregnancy unless your doctor has told you to. It is not known whether ibuprofen and pseudoephedrine passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not give this medication to a child younger than 2 years old. Ask a doctor before giving ibuprofen and pseudoephedrine to any child who has asthma.
a history of stomach ulcers or bleeding;
heart disease, congestive heart failure, high blood pressure;
systemic lupus erythematosus (SLE);
- liver or kidney disease;
a thyroid disorder;
enlarged prostate or problems with urination;
a bleeding or blood clotting disorder; or
if you smoke.
Use this medication exactly as directed on the label, or as it has been prescribed by your doctor. Do not use the medication in larger amounts, or use it for longer than recommended. Cold medicine is usually taken only for a short time until your symptoms clear up.Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. Do not take more of this medication than is recommended. An overdose of ibuprofen can cause damage to your stomach or intestines. The maximum amount of ibuprofen for adults is 800 milligrams per dose or 3200 mg per day (4 maximum doses). Use only the smallest amount of ibuprofen and pseudoephedrine needed to get relief from your pain, fever, or cold symptoms. Shake the oral suspension (liquid) well just before you measure a dose. To be sure you get the correct dose, measure the liquid with a marked measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one. Call your doctor if you have a fever lasting longer than 3 days, if you have new symptoms, or if your condition does not improve after taking this medication for 7 days.
If you need to have any type of surgery, tell the surgeon ahead of time if you have taken a cold medicine within the past few days.Store ibuprofen and pseudoephedrine at room temperature away from moisture and heat.
Since cold medicine is usually taken only as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.
Seek emergency medical attention if you think you have used too much of this medicine.
Overdose symptoms may include nausea, vomiting, stomach pain, dizziness, feeling restless or nervous, blurred vision, sweating, breathing problems, or seizure (convulsions).
Do not use any other over-the-counter cough, cold, or pain medication without first asking your doctor or pharmacist. Ibuprofen and pseudoephedrine are contained in many medicines available over the counter. If you take certain products together you may accidentally take too much of either medication. Read the label of any other medicine you are using to see if it contains ibuprofen or pseudoephedrine. Avoid drinking alcohol while taking ibuprofen and pseudoephedrine. If you drink more than 3 alcoholic beverages a day, ibuprofen may increase your risk of stomach bleeding.
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop taking this medication seek medical attention or call your doctor at once if you have any of these serious side effects:
chest pain, weakness, shortness of breath, slurred speech, problems with vision or balance;
black, bloody, or tarry stools, coughing up blood or vomit that looks like coffee grounds;
fast, pounding, or uneven heartbeat;
severe dizziness, anxiety, restless feeling, or nervousness;
easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms;
increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, seizure);
urinating less than usual or not at all;
skin rash, severe tingling, numbness, pain, muscle weakness; or
fever, headache, neck stiffness, chills, increased sensitivity to light, purple spots on the skin, and/or seizure (convulsions).
Less serious side effects may include:
upset stomach, nausea, heartburn, diarrhea, constipation;
bloating, gas, loss of appetite;
warmth, tingling, or redness under your skin;
dizziness, headache, feeling excited or restless;
sleep problems (insomnia);
skin itching or rash; or
ringing in your ears.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Before taking ibuprofen and pseudoephedrine, tell your doctor if you are taking any of the following drugs:
a blood thinner such as warfarin (Coumadin);
steroids (prednisone and others);
diuretics (water pills), or medicines to treat high blood pressure;
a beta-blocker such as atenolol (Tenormin), carteolol (Cartrol), metoprolol (Lopressor, Toprol), propranolol (Inderal), sotalol (Betapace), timolol (Blocadren), and others;
antidepressants such as amitriptyline (Elavil), clomipramine (Anafranil), imipramine (Janimine, Tofranil), and others; or
aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs) such as diclofenac (Voltaren), etodolac (Lodine), flurbiprofen (Ansaid), indomethacin, ketoprofen (Orudis), ketorolac (Toradol), mefenamic acid (Ponstel), meloxicam (Mobic), nabumetone (Relafen), naproxen (Aleve, Naprosyn), piroxicam (Feldene), and others.
This list is not complete and there may be other drugs that can interact with ibuprofen and pseudoephedrine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.
- Your pharmacist can provide more information about ibuprofen and pseudoephedrine.
Copyright 1996-2006 Cerner Multum, Inc. Version: 2.01. Revision Date: 05/07/2009 4:06:47 PM.;
- Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
- Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.